To determine the physiological reference individual values of maternal thromboelastography TEM-A during labor, immediately afeter delivery and in the postpartum period.

Estimated Enrollment:

120

Study Start Date:

November 2011

Estimated Study Completion Date:

May 2012

Estimated Primary Completion Date:

May 2012 (Final data collection date for primary outcome measure)

Intervention Details:

Device: Thromboelastography

Thromboelastography during labor and after delivery

Other Name: TEM-A automated thromboelastometer

Detailed Description:

Previous, preliminary investigations by using thromboelastography, confirmed that pregnancy is a hypercoaguable state which remains in the first 24 hours postdelivery. Unfortunately results obtained by the existing studies that attempted to establish reference values for TEG suffer considerable bias.

The aim of this study will be to determine the range values for thomboelastography in pregnant women. Since there is no available information on the expected distribution of the outcome, a sequential design will be used. The main endpoint of the analysis will be a reliable estimate for the outcome expected in healthy women after labor. The investigators will state their target estimate as being reliable when the ratio between the estimate and its standard error is smaller than 2.

During labor, 2 hours after delivery and 24 hours postpartum, a venous blood sample will be taken from eligible women for thromboelastographic determination. Whole blood nonadditive TEM will be performed on the TEM-A automated thromboelastometer (Framar Biomedica,Rome, Italy) to obtain the four classical TEM parameters: reaction (R) time, k time, alpha angle and maximum amplitude (MA).

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Please refer to this study by its ClinicalTrials.gov identifier: NCT01506102